Kornimate/medical-research-clean huggingface dataset:
tap block versus conventional systemic analgesia

Conditions: Analgesia

Summary: the goal of this clinical trial is to compare tap block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. as the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the tap block compared with the conventional systemic analgesia is considered to be clinically significant. written informed consent has to obtained from all study patients. this trial is a prospective parallel group randomized superiority trial comparing tap block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, mahmoud el matri hospital, ariana, with a 1:1 allocation ratio.

laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. the tap block is integrated within a multimodal analgesia. it corresponds to a locoregional analgesia. the goal of this clinical trial is to compare tap block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. as the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the tap block compared with the conventional systemic analgesia is considered to be clinically significant. written informed consent has to obtained from all study patients. this trial is a prospective parallel group randomized superiority trial comparing tap block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, mahmoud el matri hospital, ariana, with a 1:1 allocation ratio.

Eligibility criteria:
inclusion criteria: all patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, mahmoud el matri hospital, ariana exclusion criteria: * severe renal insufficiency (gfr \< 30 ml/min) * severe hepatic insufficiency (tt ≤ 50%) * severe copd (fev1 \> 30%) * metastatic malignancy * hematologic disease or a congenital clotting disorder * preoperative opioid use * age under 18 years * pregnancy or breast-feeding * hyper-reactivity toward ropivacaine * estimated risk for conversion to open surgery \> 50%
dipyridamole induced ischemia and biomarkers

Conditions: Ischemic Heart Disease; Ischemic Attack

Summary: analysis of certain biomarkers and transient myocardial perfusion deficit revealed by myocardial perfusion scintigraphy.

the prospectively enrolled patients were followed up to 5 years. adverse major events (mi, stroke, death) suffered during follow-up were retrospectively analysed.

Eligibility criteria:
inclusion criteria: 1. written informed consent. 2. clinical diagnosis of ischemic heart disease (ihd) - exclusion criteria: 1. refused written informed consent. 2. lost data during follow-up -
prevention of atrial fibrillation after coronary artery bypass grafting in patients with obstructive sleep apnea

Conditions: Atrial Fibrillation; Obstructive Sleep Apnea; Coronary Artery Bypass Grafting

Summary: background. atrial fibrillation is one of the most common complications in the postoperative period of coronary artery bypass grafting (cabg) surgery and usually associated with increased length of hospital stay and higher hospital costs. among the main mechanisms involved, excessive sympathetic activation, oxidative stress and inflammation are fundamental elements in the pathophysiology of obstructive sleep apnea. objectives. to evaluate the effects of continuous positive airway pressure (cpap) in reduction of atrial fibrillation after cabg in patients with obstructive sleep apnea. methodological procedures: a multicenter randomized controlled study to compare the incidence of atrial fibrillation between the intervention group and the control group, both monitored seven days with holter.


Eligibility criteria:
inclusion criteria: * apnea-hypopnea index \> 15 events/hour exclusion criteria: * ejection fraction \< 45% * chronic atrial fibrillation * periprocedural instability (haemodynamic, neurological)
perinatal care and medication assisted treatment: carbon/emery counties

Conditions: Opioid-use Disorder; Pregnancy Related

Summary: the purpose of this study is to enhance perinatal opioid use disorder (oud) treatment in a rural setting by developing an evaluated curriculum of perinatal oud provider education.

the research team will establish and evaluate a perinatal model of care for oud serving two counties, carbon and emery, which have high rates of oud and overdose. this model of care will entail university of utah medical clinicians providing education and webinars to healthcare providers in carbon/emery counties who care for pregnant women with oud and their babies. this model of care will also help other social and behavioral health care providers in the area to understand how to treat and better coordinate care. no clinical services are being provided by university of utah investigators or staff.

Eligibility criteria:
provider inclusion criteria: * must be employed as staff at one of our sub-contracted agencies or community partners * must directly provide care to pregnant women with oud in carbon and/or emery counties, ut provider exclusion criteria: * unwilling or unable to adopt treatment approaches presented from university of utah clinicians to patient care * not directly working with pregnant patients with oud
elastic abdominal binder after open abdominal surgery for benign gynecologic conditions

Conditions: Gynecologic Disease

Summary: surgery remains the backbone of modern management of benign gynecologic conditions. some common surgical procedures include hysterectomy for uterine leiomyoma or adenomyosis, adnexectomy for ovarian and tubal pathology, and other conservative surgeries. these procedures can be accomplished by different surgical approaches comprising abdominal, vaginal, and laparoscopic routes. although the use of vaginal and laparoscopic approach has increased in recent years, the open abdominal route is still the most commonly employed approach. this is especially the case in developing countries where resources to support the more expensive approach such as laparoscopy are quite limited. however, the procedure can be associated with significant morbidity. delayed functional recovery influenced by pain and immobilization are important contributing factors for increased morbidity. elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. benefits of the abdominal binder use in this patient population have not been properly examined. the aim of this study is to examine the effect of postoperative elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test \[6mwt\]) in postoperative gynecologic patients who use versus do not use the elastic abdominal binder to support incisional site.


Eligibility criteria:
inclusion criteria: * women, diagnosed with benign gynecologic conditions, undergoing open abdominal surgery exclusion criteria: * surgeries performed for cancer * intraoperative accidental injury to urinary or gastrointestinal organs * postoperative admission to intensive care unit (icu) * postoperative intraperitoneal drain placement * unable to understand and follow oral/written instructions * severe neuromuscular or circulatory disorders
a study to evaluate the long-term safety of inclacumab administered to participants with sickle cell disease

Conditions: Sickle Cell Disease; Vaso-occlusive Crisis; Vaso-occlusive Pain Episode in Sickle Cell Disease

Summary: this study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (scd). participants in this study will have completed a prior study of inclacumab.

the study will include approximately 520 adult and adolescent participants (≥ 12 years of age) with scd. all participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.

Eligibility criteria:
inclusion criteria: participants who meet all the following criteria will be eligible for study enrollment: 1. male or female participant with scd who participated and received study drug in a gbt-sponsored inclacumab clinical study. 2. participant has completed the originating inclacumab study within 30 calendar days of the day 1 visit. participants who discontinued study drug in the originating study due to a non-study drug-related ae, but who remained on study, may be eligible for treatment in this study provided the ae does not pose a risk for treatment with inclacumab. 3. female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on day 1. note: female participants who become of childbearing potential during the study must be willing to have a negative urine pregnancy test to remain in the study. 4. if sexually active, female participants of childbearing potential must consistently use highly effective methods of contraception consistently throughout the study and for at least 165 days after the last dose of study drug. if sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug. 5. participant has provided written informed consent/assent. for underage participants, both the consent of the participant's legal representative or legal guardian and the participant's assent (where applicable) must be obtained based on local requirement. exclusion criteria: participants meeting any of the following exclusion criteria will not be eligible for study enrollment: 1. female participant who is breastfeeding or pregnant. 2. participant had an infusions-related reaction (irr) in the originating inclacumab clinical study. 3. participant withdrew consent from the originating inclacumab clinical study. 4. participant was lost to follow-up from the originating inclacumab clinical study. 5. participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.

Keywords: blood disorders hemoglobin red blood cells rbcs sickle-like shape mutation in hemoglobin gene sickle cell disease scd vaso-occlusive crisis voc sca open label
ptld: multicentric retrospective study

Conditions: PTLD

Summary: this is a multicentric observational retrospective cohort study of patients with histological diagnosis of ptld. the aim of the study is to analyze the clinical features and survival of patients who received a ptld diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by ptld, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments.

this is a multicentric observational retrospective cohort study of patients with histological diagnosis of ptld. retrospective data will be collected for all cases of ptld diagnosed during a 10 years period since 1st january 2011 to 31th december 2021. the following clinical characteristics of the patient at the time of ptld diagnosis and pathology will be taken into consideration: positivity of ebv virus, serum ldh concentration, ptld subtype (early lesion, polymorphic or monomorphic ptld), lymphoma histotype, stage of disease according to the ann arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained.

Eligibility criteria:
inclusion criteria: * histological diagnosis of ptld obtained from a biopsy sample (availability of stocked biopsy sample is requested but not mandatory); * age over 18 years at time of diagnosis of ptld; * previously subjected to allogeneic transplantation (both sot and hsct); * diagnosis of ptld obtained in 10 years' time frame (from 01/01/2011 to 31/12/2021); * free and voluntary written informed consent (included unreachable subjects according to art. 36 ue regulation 2016/679 and to the current italian privacy regulation). exclusion criteria: * patients not meeting the above-mentioned inclusion criteria.

Keywords: ptld lymphoproliferative disorders transplant
quantification of metamorphopsia in patients with epiretinal membranes

Conditions: Epiretinal Membrane

Summary: aim of this study is to examine metamorphopsia before and 3 months after vitrectomy with membrane peeling among patients with idiopathic epiretinal membranes. therefore, the correlation between the alleye app and the m-chart test before and after erm surgery and the associations of oct biomarkers to postsurgical changes in metamorphopsia scores will be examined.

epiretinal membranes are common disorders leading to visual loss and metamorphopsia in later stages. in most cases they are idiopathic with no identifiable cause (ierm). erm can be visualized with optical coherence tomography (oct) and can cause metamorphopsia, usually diagnosed with the amsler grid or metamorphopsia chart (m-chart), which have influence on vision. erm are surgically treated by vitrectomy and membrane peeling, however, postoperative visual acuity and quality of vision are difficult to predict. quality of vision is highly dependent on metamorphopsia which can be an overlooked symptom. thus, detailed examinations using m-charts prior to surgery can help to quantify the degree of metamorphopsia and might predict the potential benefit of the surgery. recently, home monitoring tests for metamorphopsia using handheld mobile devices are becoming increasingly important. the alleye app is one of two m-health applications with fda approval, that is already in use for monitoring the progression of metamorphopsia in other retinal diseases such as age-related macular degeneration (amd). it has yet to be evaluated for erm. aim of this study is to examine the correlation between the alleye app and the m-chart test before and after erm surgery and the associations of oct biomarkers to postsurgical changes in metamorphopsia scores.

Eligibility criteria:
inclusion criteria: * idiopathic erm * sheduled surgery (vitrectomy with membrane peeling) * age 18 and older * written informed consent for participation in the study * metamorphopsia detected by the amsler grid * bcva ≥ 0,1 exclusion criteria: * secondary erm due to retinal tears, retinal detachment, retinal vascular diseases and uveitis * other macular disorders including amd * previous intraocular surgery except for uncomplicated cataract surgery * pregnancy (pregnancy test will be performed in women of reproductive age)
validation of kinocardiography, new technology for cardiac linear and torsional contractility measurement, to assess heart failure patient with low ejection fraction

Conditions: Impaired Left Ventricular Ejection Fraction

Summary: measuring cardiac contractility is commonly realized with gold standard echocardiography or mri. portable devices to measure this contractility are not available as for rhythm and electric function assessment. the new kinocardiography technology could provide a non invasive and portable tool to measure contractility. this device records the electric and mechanic function of the heart simultaneously. with electrodes and adequate electronics, ecg is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. using physics principles and adequate calibration, those accelerations allow the investigators to calculate parameters such as kinetics energies related to cardiac contractility. kinocardiography is a non invasive and portable technology.


Eligibility criteria:
inclusion criteria: * control group: left ventricle ejection fraction ≥ 50 % * heart failure patients: left ventricle ejection fraction \< 50 % exclusion criteria: * intracardiac devices and arrhythmia at the time of assessment * participates in other clinical study or trial.

Keywords: kinocardiography cardiac contractility heart kinetic energy
meal-induced thrombin generation before and after gastric bypass

Conditions: Morbid Obesity; Weight Loss

Summary: the purpose of this study is to investigate harmful effects of intentional weight loss. intentional weight loss has been linked to increased risk of cardiovascular disease in overweight individuals, but the link between intentional weight loss and thrombotic disease is poorly understood. postprandial coagulation activation, including thrombin generation, is a potential mechanism after high-fat meals. thirty obese patients admitted to gastric bypass will be included in a randomized, cross-over clinical trial. all patients will consume a high-fat meal and a low-fat meal served in a randomized order on two study days (two to seven days apart). this cross-over study will be carried out before weight loss, during lifestyle-induced weight loss, and during weight loss 3-4 months after gastric bypass. fasting and postprandial blood samples are collected on each study days, while one fecal sample is collected for each study period. the study will contribute to our understanding of mechanisms underlying harmful effects of weight loss, and future, dietary guidelines in relation to intentional weight loss programs must be modified.


Eligibility criteria:
inclusion criteria: * eligible for gastric bypass surgery exclusion criteria: * use of anticoagulants, platelet inhibitors and oral contraceptives * known liver diseases, any malignant disorders, or known coagulation diseases

Keywords: gastric bypass
probiotic after acute colonic diverticulitis

Conditions: Diverticulitis, Colonic; Therapy

Summary: the goal of this observational study is to assess the efficacy and safety of the probiotic escherichia coli nissle 1917 (ecn®, ca.di.group s.p.a) in the treatment of symptomatic patients after an episode of both complicated and uncomplicated acute colonic diverticulitis. the main question it aims to answer are: * is the studied probiotic able to significantly reduce symptoms, assessed by means of a validated and dedicated score? * is there any difference in microbiota among the study group at baseline and a selected cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects after an episode of acute uncomplicated diverticulitis or an episode of complicated diverticulitis submitted to surgery with colonic resection without stoma? * is there any difference in microbiota in the study group at baseline and after 3 and 6 months of treatment with the probiotic? * is there any correlation between microbiota modification and symptoms during follow-up? * is there any impact on fecal calprotectin values before and during probiotic therapy? * is there any modification of evacuation before and during follow-up? * is probiotic able to prevent recurrent episodes of acute diverticulitis during follow-up? * the safety of the probiotic will be assessed during the follow-up. the study group will be assessed at baseline and during follow-up with a dedicated clinical score and bristol stool scale. microbiota and fecal calprotectin values will be also assessed at baseline and during follow-up. microbiota at baseline will be also evaluated for comparison in the three selected groups with diverticulosis and both asymptomatic and symptomatic after an episode of acute diverticulitis.


Eligibility criteria:
inclusion criteria: * symptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis; * symptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to .surgical colonic resection without stoma; * patients with diverticulosis; * asymptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis; * asymptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to surgical colonic resection without stoma. exclusion criteria: * ongoing acute diverticulitis at radiologic assessment * antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazine within four weeks before enrolment; * lactulose-lactitol use within four weeks before enrolment; * presence of chronic inflammatory bowel diseases; * presence of segmental colitis associated with diverticulitis (scad); * presence of ischemic colitis; * severe chronic liver (child-pugh c) and/or pancreatic and/or renal diseases; * patients with severe renal failure; * presence of suspected/actual pregnancy; * presence of recent/ongoing neoplasia, under oncological treatment within 6 months before enrolment; * presence of covid-19 infection; * patients unable to give informed consent.
safety and tolerability of oral lcl161 in japanese adult patients with advanced solid tumors

Conditions: Neoplasms

Summary: this study will evaluate safety and tolerability to estimate the maximum tolerated dose and/or recommended dose of oral lcl161 in japanese patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. patients with a histologically or cytologically confirmed diagnosis of a solid tumor for which no further effective standard treatment is available. 2. ecog performance status 0-1. 3. patients must have recovered from all toxicities related to their previous treatment. exclusion criteria: 1. unresolved nausea, vomiting, diarrhea or peripheral neuropathy ctcae grade \>1. 2. history of or current interstitial lung disease or autoimmune disease. 3. history of or current impaired cardiac function or clinically significant cardiac diseases. 4. women of child-bearing potential, unless they are using highly effective methods of contraception. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lcl161, paclitaxel, japanese patient, neoplasms